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Synbiotic Treatment of Ulcerative Colitis Patients

U

University of Dundee

Status

Completed

Conditions

Ulcerative Colitis

Treatments

Other: Synbiotic (Synergy1/B. longum)

Study type

Interventional

Funder types

Other

Identifiers

NCT00803829
REC: 08/S1402/45
RD: 2007GA08
NACC: M/08/2
20509

Details and patient eligibility

About

Ulcerative colitis (UC) is one of the two main forms of inflammatory bowel disease. UC is associated with high morbidity and incurs significant social, commercial and NHS costs. For a variety of reasons, many patients are refractile to standard therapies, which often have undesirable side-effects. However, an inexpensive and non-toxic treatment based on the synbiotic concept may prove to be effective in these individuals. A synbiotic is a mixture of a probiotic (a live microorganism) and a prebiotic, which is a carbohydrate that serves as a food source for the probiotic, allowing it to grow better in the gut. The aim of this study is to determine whether a synbiotic comprised of fructooligosaccharides and inulin, together with a bifidobacterial probiotic (Bifidobacterium longum), that we have previously shown to reduce inflammatory processes in the gut wall (mucosa) in a short-term pilot trial, can colonise the bowel, reduce mucosal inflammation, and induce remission in UC patients with active disease. It is planned to establish a double-blinded, controlled, randomised investigation involving 46 patients for six months. If the results from our pilot study can be reproduced and maintained in a long-term investigation, the synbiotic could become available very quickly, and would provide an inexpensive and effective treatment for UC, making a significant contribution to relieving the clinical and financial burdens of this disease.

Enrollment

24 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Ulcerative colitis
  • Stable doses of medications for UC for the preceding three months
  • Mayo score of 6 to 12
  • Sigmoidoscopy subscore of 2
  • Stable doses of medication

Exclusion criteria

  • Pregnancy
  • Lactation
  • Antibiotic therapy in the last three months
  • Probiotic or prebiotic therapy in the last month
  • Crohn's Disease, indeterminate colitis
  • Alterations to medications in the last three months

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Triple Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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